Prophylaxis Vaccine Antibodies Ebola

Phase 2

• Conditions: Ebola Virus Disease
• Interventions: Drug: ansuvimab; Biological: Ervebo

• Registration Number: NCT04822376
• Lead Sponsor: ANRS, Emerging Infectious Diseases

Brief Summary

* Three measures are currently being implemented to control Ebola outbreaks:

* Monitoring of contacts

* Isolation and treatment of sick people

* Vaccination of the population in high-risk areas.

* In contacts with high viral exposure and therefore a high risk of incubation and rapid expression of infection, the r-VSV-ZEBOV vaccine does not provide adequate protection because vaccine antibody production is effective 6 to 10 days after administration.

* Specific monoclonal antibodies (Mab) from the Regeneron and mAb114 research specialties have been shown to be effective in reducing mortality in patients with Ebola virus disease (EVD).

* Their use in a single parenteral administration and good tolerability make them candidates for use in post-exposure prophylaxis (PEP) in individuals at high risk of viral exposure.

* A comprehensive strategy for the protection of high-risk contacts must therefore be implemented, including the vaccine and the Mabs, to ensure both immediate and prolonged protection. Indeed, the efficacy of the vaccine is likely to be diminished when co-administered with Mabs, as both strategies share the same viral target (the GP envelope glycoprotein) and the vaccine is replicative (and therefore may be inhibited by Mabs).

PROVAE aim to evaluate the effectiveness of a comprehensive strategy to prevent transmission of MVE in contacts at high risk of infection, including (i) post-exposure prophylaxis with Mabs and (ii) vaccination with r-VSV-ZEBOV.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-26
• Study First Submitted QC: 2021-03-26
• Study First Posted: 2021-03-30
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-14
• Last Update Posted: 2021-10-15
• Study Start: 2021-10-17
• Primary Completion: 2022-04
• Study Completion: 2022-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
High risk arm	ansuvimab	Mabs at day 0 and vaccine at week 6
High risk arm	Ervebo	Mabs at day 0 and vaccine at week 6
High risk arm (Immunological ancillary study)	ansuvimab	Mabs at day 0 and vaccine at week 6
High risk arm (Immunological ancillary study)	Ervebo	Mabs at day 0 and vaccine at week 6
Control arm (Immunological ancillary study)	Ervebo	Vaccine at day 0 for contacts eligible for vaccination

Primary Outcome Measures

Name	Time	Method
Efficacy	Week 3	Proportion of participants with negative RT-PCR
Immunological ancillary study	6 months after vaccination	Anti-GP IgG level (FANG reference technique)

Secondary Outcome Measures

Name	Time	Method
Tolerance	Day 7 post-PEP and day 7 post-vaccination	Estimating adverse effects
Lost of follow-up	Week 6	Lost of follow-up rate
Humoral immune response	1 and 3 months after vaccination	Anti-GP IgG level (FANG reference technique)
Neutralizing antibodies	1, 3 and 6 months after vaccination	Neutralizing antibodies level

Trial Locations

Locations (1)

Centre de Traitement Ebola de N'Zerekore; 🇬🇳 N'Zerekore, Guinea